Kimberly began her career in healthcare 20+ years ago as a Surgical Oncology Nurse before changing career paths to clinical research in 2013. She has since worked as a Regulatory Affairs Assistant, a Clinical Trial Associate, and now as a Manager of Clinical Trials Documentation at Zydus Therapeutics. In her current role, she is responsible for ensuring that the Clinical Operations team understands the nuances of document management and how to leverage the available tools and resources to create a culture of inspection readiness. Having worked in both sponsor and CRO environments, she has a comprehensive appreciation of the value of time and quality, and she is a firm believer in doing it right the first time.
We will present a case study on how the two organizations partnered to switch gears and level up TMF processes, seeing over an 80% increase in efficiency in documentation management, a significant improvement in oversight and a 65% increase in timeli
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